Not provided
Not provided
Not provided
Not provided
Study product bottles were found on site that did not meet product specifications. This prompted a 6-week safety review of participants (no study-related findings) and resulted in the study's termination.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Maseno University | OTHER |
| Kakamega County General Teaching & Referral Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
This is a randomized, double-blinded, placebo-controlled pilot study to determine the safety, acceptability, and feasible pediatric dosage/tolerability of enterade® solution, an amino acid-based oral rehydration solution (AA-ORS), for potential use in the management of environmental enteric dysfunction (EED) among children aged 12-24 months in Kakamega County, Kenya.
Primary objectives:
To determine the safety of a 2-week course of AA-ORS among children with length-for-age Z-scores (LAZ) between -1 and -3.
To determine the feasibility and best tolerated dose of AA-ORS among children with LAZ between -3 and -1.
Secondary objectives:
To determine the perceptions among caregivers on the acceptability of AA-ORS as a potential intervention for EED. (Qualitative)
Exploratory objectives:
To determine the impact of AA-ORS on markers of metabolism, gut dysfunction, systemic inflammation, and micronutrient status among children with LAZ between -3 and - 1.
Qualitative results will not be reported on ClinicalTrials.gov.
Environmental enteric dysfunction (EED) is an intestinal disorder common among people living in low-resource settings (LRS), which in children has been associated with increased risk of growth stunting, reduced cognitive development, and reduced oral vaccine responsiveness. An effective EED therapeutic would offer an opportunity to improve child growth and development in LRS. One promising intervention, enterade® (an amino acid-based oral rehydration solution [AA-ORS]), is a medical food product already sold in the United States. It consists of oral rehydration salts and a proprietary blend of amino acids designed to restore gut function, improve nutrient and electrolyte absorption, and improve barrier integrity. There is evidence that this AA-ORS reduces inflammation and promotes healing of damaged intestinal epithelium in murine models of intestinal damage (irradiated gut), and it may provide benefit to pediatric EED patients. Supplementation of amino acids may lessen or improve intestinal injury related to enteric illnesses commonly experienced in settings of poor hygiene and sanitation infrastructure. The results from this exploratory mixed-methods study could have broad implications for possible future studies among pediatric patients with intestinal injury resulting from EED and future product development and program strategies for EED interventions.
The study was terminated prematurely after study product was found on site that did not meet product specifications. Enrollment and all study product dosing was halted; previously enrolled participants were followed through planned study visits and assessments. An additional 6-week safety follow-up period was added to study procedures. No study-related adverse events were reported during per-protocol activities or from the additional 6-week follow-up.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AA-ORS | Experimental | Those receiving enterade oral re-hydration solution with amino acids |
|
| Placebo | Placebo Comparator | Those receiving placebo solution without amino acids or rehydration salts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enterade | Dietary Supplement | enterade® (an amino acid-based oral rehydration solution [AA-ORS]) is a medical food product that consists of oral rehydration salts, natural flavor, steviol (sweetener), purified water, and a blend of amino acids that drive the uptake of water and electrolytes. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Events or Serious Adverse Events | Frequency of adverse events or serious adverse events in study product and placebo arms through 21 days of follow-up as assessed by physical/clinical examination. | 0-21 days |
| Volume of Daily Consumption of Study Product | Total, average, and trends in daily study product volume consumed measured as milliliters per day through the 14 days of dosing. | 0-14 days |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory - Metabolism: Plasma Concentration of Acylcarnitines | Plasma concentration of acylcarnitines assessed at baseline and day 15 of follow-up. | Day 0 and Day 15 |
| Exploratory - Gut Damage: Plasma Concentration of Intestinal Fatty Acid-binding Protein [I-FABP] |
Inclusion Criteria:
Pediatric and caregiver pairs (must meet inclusion criteria for both categories):
Child:
Caregiver of child:
Exclusion Criteria:
Pediatric and caregiver pairs (must meet none of the exclusion criteria for either category):
Child:
Caregiver:
Reports diarrhea in the household in the prior 7 days.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kakamega County General Teaching and Referral Hospital | Kakamega | Kenya |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AA-ORS | Those receiving enterade oral re-hydration solution with amino acids Enterade: enterade® (an amino acid-based oral rehydration solution [AA-ORS]) is a medical food product that consists of oral rehydration salts, natural flavor, steviol (sweetener), purified water, and a blend of amino acids that drive the uptake of water and electrolytes. |
| FG001 | Placebo | Those receiving placebo solution without amino acids or rehydration salts Placebo: a placebo solution containing natural flavor, steviol (sweetener), and purified water. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AA-ORS | Those receiving enterade oral re-hydration solution with amino acids Enterade: enterade® (an amino acid-based oral rehydration solution [AA-ORS]) is a medical food product that consists of oral rehydration salts, natural flavor, steviol (sweetener), purified water, and a blend of amino acids that drive the uptake of water and electrolytes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Adverse Events or Serious Adverse Events | Frequency of adverse events or serious adverse events in study product and placebo arms through 21 days of follow-up as assessed by physical/clinical examination. | This is the intention-to-treat population with all participants randomized and received at least one dose. | Posted | Count of Participants | Participants | 0-21 days |
|
21 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AA-ORS | Those receiving enterade oral re-hydration solution with amino acids Enterade: enterade® (an amino acid-based oral rehydration solution [AA-ORS]) is a medical food product that consists of oral rehydration salts, natural flavor, steviol (sweetener), purified water, and a blend of amino acids that drive the uptake of water and electrolytes. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gwen Ambler, Clinical Research Officer | PATH | +1-206-285-3500 | gambler@path.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 28, 2018 | Jul 23, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006130 | Growth Disorders |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
This is a mixed-methods pilot study to assess the safety, acceptability, and feasible dosage of AA-ORS among children with mild to moderate stunting (LAZ between -1 and -3) who are at risk for EED and to assess the acceptability of this fluid supplementation for their caregivers. During the main study, up to 66 child participants will be randomized to receive 14 days of AA-ORS or placebo solution daily, dosing of up to 237 ml over a 3-hour period. Study staff and participants will be blinded to the study product allocation. Caregivers will store and return unused study product. Data collection methods to include direct observation of product consumption, structured surveys with caregivers, average daily volume consumed, and measurement of plasma/serum markers of metabolism, gut dysfunction, systemic inflammation, and micro-nutrient status pre- and post-administration of product.
Not provided
Not provided
Not provided
|
| Placebo | Dietary Supplement | a placebo solution containing natural flavor, steviol (sweetener), and purified water. |
|
Plasma concentration of intestinal fatty acid-binding protein [I-FABP] assessed at baseline and day 15 of follow-up. |
| Day 0 and Day 15 |
| Exploratory - Microbial Translocation: Plasma Concentration of Soluble CD14 [sCD14] | Plasma concentration of soluble CD14 [sCD14] assessed at baseline and day 15 of follow-up. | Day 0 and Day 15 |
| Exploratory - Gut Repair: Plasma Concentration of Glucagon-like Peptide 2 [GLP-2] | Plasma concentration of glucagon-like peptide 2 [GLP-2] assessed at baseline and day 15 of follow-up. | Day 0 and Day 15 |
| Exploratory - Growth Hormone Axis: Plasma Concentration of Insulin-like Growth Factor 1 [IGF-1] | Plasma concentration of insulin-like growth factor 1 [IGF-1] assessed at baseline and day 15 of follow-up. | Day 0 and Day 15 |
| Exploratory - Growth Hormone Axis: Plasma Concentration of Fibroblast Growth Factor 21 [FGF21] | Plasma concentration of fibroblast growth factor 21 [FGF21] assessed at baseline and day 15 of follow-up. | Day 0 and Day 15 |
| Exploratory - Systemic Inflammation: Plasma Concentration of Alpha-1-acid Glycoprotein [AGP] | Plasma concentration of alpha-1-acid glycoprotein [AGP] assessed at baseline and day 15 of follow-up. | Day 0 and Day 15 |
| Exploratory - Systemic Inflammation:Plasma Concentration of C-reactive Protein [CRP] | Plasma concentration of c-reactive protein [CRP] assessed at baseline and day 15 of follow-up. | Day 0 and Day 15 |
| Exploratory - Micronutrient Status: Plasma Concentration of Ferritin | Plasma concentration of ferritin assessed at baseline and day 15 of follow-up. | Day 0 and Day 15 |
| Exploratory - Micronutrient Status: Plasma Concentration of Soluble Transferrin Receptor [sTfR] | Plasma concentration of soluble transferrin receptor [sTfR] assessed at baseline and day 15 of follow-up. | Day 0 and Day 15 |
| Exploratory - Micronutrient Status: Plasma Concentration of Retinol-binding Protein 4 [RBP4] | Plasma concentration of retinol-binding protein 4 [RBP4] assessed at baseline and day 15 of follow-up. | Day 0 and Day 15 |
| Exploratory - Micronutrient Status: Plasma Concentration of Thyroglobulin | Plasma concentration of thyroglobulin assessed at baseline and day 15 of follow-up. | Day 0 and Day 15 |
| BG001 |
| Placebo |
Those receiving placebo solution without amino acids or rehydration salts Placebo: a placebo solution containing natural flavor, steviol (sweetener), and purified water. |
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Length | Median | Full Range | cm |
|
| Weight | Median | Full Range | kg |
|
| Mid-upper arm circumference (MUAC) | Median | Full Range | mm |
|
| Placebo |
Those receiving placebo solution without amino acids or rehydration salts Placebo: a placebo solution containing natural flavor, steviol (sweetener), and purified water. |
|
|
| Primary | Volume of Daily Consumption of Study Product | Total, average, and trends in daily study product volume consumed measured as milliliters per day through the 14 days of dosing. | Intention-to-treat | Posted | Median | Full Range | ml | 0-14 days |
|
|
|
| Other Pre-specified | Exploratory - Metabolism: Plasma Concentration of Acylcarnitines | Plasma concentration of acylcarnitines assessed at baseline and day 15 of follow-up. | Due to study termination, exploratory analyses were not conducted on specimens collected. | Posted | Day 0 and Day 15 |
|
|
| Other Pre-specified | Exploratory - Gut Damage: Plasma Concentration of Intestinal Fatty Acid-binding Protein [I-FABP] | Plasma concentration of intestinal fatty acid-binding protein [I-FABP] assessed at baseline and day 15 of follow-up. | Due to study termination, exploratory analyses were not conducted on specimens collected. | Posted | Day 0 and Day 15 |
|
|
| Other Pre-specified | Exploratory - Microbial Translocation: Plasma Concentration of Soluble CD14 [sCD14] | Plasma concentration of soluble CD14 [sCD14] assessed at baseline and day 15 of follow-up. | Due to study termination, exploratory analyses were not conducted on specimens collected. | Posted | Day 0 and Day 15 |
|
|
| Other Pre-specified | Exploratory - Gut Repair: Plasma Concentration of Glucagon-like Peptide 2 [GLP-2] | Plasma concentration of glucagon-like peptide 2 [GLP-2] assessed at baseline and day 15 of follow-up. | Due to study termination, exploratory analyses were not conducted on specimens collected. | Posted | Day 0 and Day 15 |
|
|
| Other Pre-specified | Exploratory - Growth Hormone Axis: Plasma Concentration of Insulin-like Growth Factor 1 [IGF-1] | Plasma concentration of insulin-like growth factor 1 [IGF-1] assessed at baseline and day 15 of follow-up. | Due to study termination, exploratory analyses were not conducted on specimens collected. | Posted | Day 0 and Day 15 |
|
|
| Other Pre-specified | Exploratory - Growth Hormone Axis: Plasma Concentration of Fibroblast Growth Factor 21 [FGF21] | Plasma concentration of fibroblast growth factor 21 [FGF21] assessed at baseline and day 15 of follow-up. | Due to study termination, exploratory analyses were not conducted on specimens collected. | Posted | Day 0 and Day 15 |
|
|
| Other Pre-specified | Exploratory - Systemic Inflammation: Plasma Concentration of Alpha-1-acid Glycoprotein [AGP] | Plasma concentration of alpha-1-acid glycoprotein [AGP] assessed at baseline and day 15 of follow-up. | Due to study termination, exploratory analyses were not conducted on specimens collected. | Posted | Day 0 and Day 15 |
|
|
| Other Pre-specified | Exploratory - Systemic Inflammation:Plasma Concentration of C-reactive Protein [CRP] | Plasma concentration of c-reactive protein [CRP] assessed at baseline and day 15 of follow-up. | Due to study termination, exploratory analyses were not conducted on specimens collected. | Posted | Day 0 and Day 15 |
|
|
| Other Pre-specified | Exploratory - Micronutrient Status: Plasma Concentration of Ferritin | Plasma concentration of ferritin assessed at baseline and day 15 of follow-up. | Due to study termination, exploratory analyses were not conducted on specimens collected. | Posted | Day 0 and Day 15 |
|
|
| Other Pre-specified | Exploratory - Micronutrient Status: Plasma Concentration of Soluble Transferrin Receptor [sTfR] | Plasma concentration of soluble transferrin receptor [sTfR] assessed at baseline and day 15 of follow-up. | Due to study termination, exploratory analyses were not conducted on specimens collected. | Posted | Day 0 and Day 15 |
|
|
| Other Pre-specified | Exploratory - Micronutrient Status: Plasma Concentration of Retinol-binding Protein 4 [RBP4] | Plasma concentration of retinol-binding protein 4 [RBP4] assessed at baseline and day 15 of follow-up. | Due to study termination, exploratory analyses were not conducted on specimens collected. | Posted | Day 0 and Day 15 |
|
|
| Other Pre-specified | Exploratory - Micronutrient Status: Plasma Concentration of Thyroglobulin | Plasma concentration of thyroglobulin assessed at baseline and day 15 of follow-up. | Due to study termination, exploratory analyses were not conducted on specimens collected. | Posted | Day 0 and Day 15 |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | Placebo | Those receiving placebo solution without amino acids or rehydration salts Placebo: a placebo solution containing natural flavor, steviol (sweetener), and purified water. | 0 | 6 | 0 | 6 | 0 | 6 |
Not provided
Not provided
Not provided